Home › MICROPORT CRM SRL › BlueSky

BlueSky

MICROPORT CRM SRL · Model TPM020U · UDI-DI 08031527018997

DXY Prescription

510(k) clearances

57,769

Adverse events (1,952 deaths)

Recalls

Facilities

Description

BlueSky DR Alizea 1600

Recalls

Date	Firm	Reason
2022-06-17	St. Jude Medical, Cardiac Rhythm Management Division	There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain p
2022-06-17	St. Jude Medical, Cardiac Rhythm Management Division	The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices
2022-06-17	St. Jude Medical, Cardiac Rhythm Management Division	The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices
2017-08-28	St Jude Medical Inc.	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
2017-08-28	St Jude Medical Inc.	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
2017-08-28	St Jude Medical Inc.	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
2017-08-28	St Jude Medical Inc.	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
2011-09-23	St Jude Medical CRMD	St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during v
2011-09-23	St Jude Medical CRMD	St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during
2010-02-11	Medtronic Inc. Cardiac Rhythm Disease Managment	Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software up

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.